Label: CETAFEN COUGH AND COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coated

  • NDC Code(s): 50332-0141-3, 50332-0141-4, 50332-0141-7
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 10, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 100 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these cold and flu symptoms

    • cough
    • sore throat
    • headache
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
    • helps loosen phlegm (mucus) and bronchial secretions to coughs more productive

    Temporarily reduces fever

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

  • DO NOT USE

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription)
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains an MAOI
  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart, liver, or thyroid disease
    • high blood pressure
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate 
    • a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin
    • you do not know if other drugs you are taking contain acetaminophen
  • STOP USE

    Stop use and ask a doctor if
    • an allergic reaction occurs, seek medical help right away
    • redness or swelling is present
    • you get nervous, dizzy, or sleepless
    • new symptoms occur
    • fever worsens or lasts more than 3 days
    • pain, nasal congestion, or cough worsens or lasts more than 7 days
    • cough comes back or occurs with a rash or headache that lasts

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions

    Do not take more than directed

    Adults and children 12 years of age and over

    • take 2 caplets every 6 to 8 hours while symptoms persist
    • do not take more than 8 caplets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information:

    • caplets enclosed in a sealed packet
    • do not use if packet is torn, cut or open
    • store at 59° to 86°F (15°-30°C)
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    CetafenCough.jpg

  • INGREDIENTS AND APPEARANCE
    CETAFEN COUGH AND COLD 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0141-320 in 1 BAG01/09/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0141-440 in 1 BOX01/09/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0141-7100 in 1 BOX01/09/2023
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/09/2023
    Labeler - HART Health (069560969)